早期乳腺癌的延长辅助他莫昔芬治疗：一项荟萃分析。
Extended adjuvant tamoxifen for early breast cancer: a meta-analysis.
机构信息
Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre and Department of Medicine, University of Toronto, Toronto, Canada ; Ministry of Higher Education, Riyadh, Saudi Arabia.
Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre and Department of Medicine, University of Toronto, Toronto, Canada.
出版信息
PLoS One. 2014 Feb 20;9(2):e88238. doi: 10.1371/journal.pone.0088238. eCollection 2014.
BACKGROUND
Hormone receptor positive breast cancer is characterized by the potential for disease recurrence many years after initial diagnosis. Endocrine therapy has been shown to reduce the risk of such recurrence, but the optimal duration of endocrine therapy remains unclear.
METHODS
We conducted a systematic review and meta-analysis to quantify the benefits and harms of extended adjuvant tamoxifen (>5 years of therapy) compared with adjuvant tamoxifen (5 years of therapy). Odds ratios (ORs) and 95% confidence intervals (CIs) were computed for disease recurrence, death and adverse events. Subgroup analyses by timing of recurrence and baseline lymph node and menopause status were carried.
RESULTS
Five trials comprising 21,554 patients were included. Extended adjuvant tamoxifen was not associated with a significant reduction in the risk of recurrence (OR:0.89, 95% CI 0.76-1.05, p = 0.17). There was no association between extended adjuvant tamoxifen and all-cause death (OR:0.99, 95% CI 0.84-1.16, p = 0.88). There was an apparent reduction in risk of recurrence occurring after completion of extended adjuvant tamoxifen with little evidence of effect during therapy, however, this difference was not significant (p for difference 0.10). Subgroup analysis suggested that a greater effect size among lymph node positive patients compared with those who are lymph node negative (NNT: 25 vs. 49). There was no apparent difference in the effect between pre- and post-menopausal patients. Endometrial carcinoma was substantially more frequent with extended adjuvant tamoxifen (OR:2.06, 95% CI 1.65-2.58, p<0.001, number needed to harm:89).
CONCLUSION
In unselected patients, extended adjuvant tamoxifen is not associated with a significant reduction in recurrence, or a reduction in all-cause death. Patients with lymph node positive breast cancer may derive some benefit. Reduction in the risk of recurrence appears to occur only after completion of extended adjuvant therapy.
背景
激素受体阳性乳腺癌的特征是在初始诊断多年后可能出现疾病复发。内分泌治疗已被证明可降低这种复发的风险，但内分泌治疗的最佳持续时间仍不清楚。
方法
我们进行了系统评价和荟萃分析，以量化延长辅助他莫昔芬（治疗时间超过 5 年）与辅助他莫昔芬（治疗时间 5 年）相比的获益和危害。计算了疾病复发、死亡和不良事件的比值比（OR）和 95%置信区间（CI）。进行了按复发时间和基线淋巴结状态和绝经状态的亚组分析。
结果
纳入了 5 项试验，共 21554 名患者。延长辅助他莫昔芬与复发风险降低无关（OR：0.89，95%CI 0.76-1.05，p=0.17）。延长辅助他莫昔芬与全因死亡无关（OR：0.99，95%CI 0.84-1.16，p=0.88）。在完成延长辅助他莫昔芬治疗后，复发风险明显降低，但在治疗期间几乎没有效果，然而，这种差异没有统计学意义（差异 p 值为 0.10）。亚组分析表明，淋巴结阳性患者的效果比淋巴结阴性患者更大（NNT：25 与 49）。在绝经前和绝经后患者之间，效果没有明显差异。子宫内膜癌的发病率明显增加（OR：2.06，95%CI 1.65-2.58，p<0.001，需要治疗的人数：89）。
结论
在未选择的患者中，延长辅助他莫昔芬与复发率降低或全因死亡率降低无关。淋巴结阳性乳腺癌患者可能会从中获益。复发风险的降低似乎仅在完成延长辅助治疗后才会发生。
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